MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly

MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly is an FDA 510(k)-cleared medical device (K180902) manufactured by Medipines Corporation. This device is classified under the Anesthesiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 10, 2019. Regulation: 8.